PI 341A: Quality Management(PI)

(Open Elective)
Prof. Arvind Kumar Verma
Dept. of Production and Industrial Engineering
MBM University, Jodhpur
Mobile:9414918856
Email: akverma.pi@jnvu.edu.in
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What is Quality?
There are two viewpoints of quality that coexist and cooperate.
 Producers (manufacturers or service providers) view quality as a
set of standards and specifications that must be met (Quality of
conformance). — Philip B. Crosby
 Customers view Quality as the ability of a product or service to
consistently meet or exceed their expectations (Quality of fitness
for use). — W. Edwards Deming
 Quality is a customer determination, not an engineer’s
determination, not a marketing determination, nor a general
management determination. It is based upon the customer’s actual
experience with the product or service, measured against his or
her requirements — stated or unstated, conscious or merely
sensed, technically operational or entirely subjective — and always
representing a moving target in a competitive market.”— Armand
3
V. Feigenbaum
WHAT IS A QUALITY MANAGEMENT SYSTEM ?

 A quality management system is defined as a

formalized system that documents processes,
procedures, and responsibilities for achieving quality
policies and objectives. A QMS helps coordinate and
direct an organization’s activities to meet customer
and regulatory requirements and improve its
effectiveness and efficiency on a continuous basis.
 ISO 9001:2015, the international standard specifying
requirements for quality management systems, is the
most prominent approach to quality management
systems. It refers to the entirety of the system and the
documents only serve to describe the system.
BENEFITS OF QUALITY MANAGEMENT SYSTEMS
 Implementing a quality management system affects every aspect of an
organization's performance. Benefits of a documented quality
management system include:
 Meeting the customer’s requirements, which helps to instill
confidence in the organization, in turn leading to more customers,
more sales, and more repeat business.
 Meeting the organization's requirements, which ensures compliance
with regulations and provision of products and services in the most
cost- and resource-efficient manner, creating room for expansion,
growth, and profit.
 Defining, improving, and controlling processes.
 Reducing waste, Preventing mistakes, and Lowering costs.
 Facilitating and identifying training opportunities.
 Engaging staff.
 Myths about Quality
 There are myths about Quality in product development:
 Production of a defect free product is quality.
 The product quality is the sole responsibility of the
Quality Department.
 QA team only checks if the features work correctly
after the final product production.

 A defect discovered by the QA team at the requirements

testing stage costs 10 times less than if it is discovered
after the feature has been deployed.
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Voice of the Customer
 There are two types of needs or requirements from
customers:
 Stated needs where a customer is able to state or
describe what they want in a product.
 Unstated needs are needs or requirements that the
customer takes for granted and needs that they
don’t realize they have or think about.
 One of the ways to identify these unstated or latent
needs is by observing the customer use the product and
through other voice of the customer techniques.
Voice of the Customer
 Another unstated need that a customer takes for granted is that
the product will reliably perform in the environment that they
operate in and the manner in which they would normally use
their product.
 The challenges with product development are the customer’s
use environment, the level or frequency of use of a product and
the way the product is stored and cared for can vary
significantly.
 The best way to accomplish this is to get out in the field and
explore and observe customer’s use environment. Then
typically, the product developer will define the extreme
conditions of the use environment as the basis for the product
requirements (e.g., upper and lower temperature range, upper
and lower humidity level, maximum duty cycle, etc.)
Knowledge Areas an a New Product Design
 Product Development Process (PDP)
 PDP is the process of bringing new products to market. It may include
phases of market surveys, idea and concept generation, system
engineering, detailed design, and also preparation for production.

Project The need Product Complete Prototype Production

mission analysis and architecture specification developme run, workforce
statement development definition & of the nt and its training
of alternative its geometry, testing and and identify
product decompositi materials, and refinement problems in
concepts and on into tolerances of the production
selection of product parts and processes.
concepts for subsystems selection of
the next step and standard parts
components
How Much Quality?
• Producers strive to balance the market forces for high quality with
consumers’ cost preferences and the company’s production
capabilities.
• One should strive to achieve the quality level at which the profit is
maximized.

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Dimensions of Quality
 The dimensions of quality are the descriptors that must be examined
to determine the quality of a product.
 For example:
 The quality of wine is characterized by smell, color, and taste and
chemical composition.
 Cars are evaluated within categories of cost, by their power,
safety features, capacities, fuel efficiencies, and style.
 When rating the quality of cities to live in, the criteria include
amount of crime, cost of living, job availability, transportation,
winter mildness, and the quality of schools for children.

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Common Quality dimensions
Eight Quality dimensions proposed by David
Garvin:
 Performance
 Features
 Reliability
 Conformance
 Durability
 Serviceability
 Aesthetics
 Perceived quality 14
Common Quality dimensions
 The performance dimension relates to the quality of the
fundamental purpose for which the product is purchased. How
well does the car do what it is supposed to do? Are the rooms
quiet and the beds comfortable?
 The features dimension refers to product capabilities not
considered to be part of normal performance expectations. These
might be GPS and satellite radio for the car, or a spa and access to
the internet for the resort guests.
 The reliability dimension relates to performance that can be
depended upon with a high level of assurance. The car starts,
drives, and does not break down. If the windshield wipers do not
work, there is a reliability problem. For the resort, if the room
key does not work all of the time, there is a reliability problem.
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Common Quality dimensions
 The conformance dimension decides to the degree to
which the measured production qualities correspond to
the design quality standards that have been specified.
Windshield wipers are not supposed to fail for the first
five years and the room key is expected to work for a
normal stay.

 The durability dimension deals with how well the

product endures in the face of use and stress. Some cars
are roadworthy after being driven more than 100,000
miles.
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 Common Quality dimensions
 The serviceability dimension is related to how often service is
required; and how difficult, and how costly it is to service and
repair the product. Serviceability for both cars and resort rooms
involves the combination of preventive and remedial maintenance.
 The aesthetics dimension refers to the appearance of the product.
For both autos and resorts, design styling is important.
 The perceived quality dimension relates to the customers’
perceptions of the product’s quality and value received for money
paid. How much will you pay for a Tesla?
For different individuals, certain dimensions are more important
than others. 17
 Costs of Quality
There are three basic costs of quality that include:
 The Cost of Prevention,
 The Cost of Appraisal (Inspection)
 The Cost of Failure

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MEANING OF CONTROL
 Control is a system for measuring and checking (inspecting) a
phenomenon and taking a corrective action based on some
feedback.
 Control incorporates a feedback mechanism which explores the
causes of poor quality and takes corrective action.
 Control differs from ‘inspection’, as it ascertains quality
characteristics of an item, compares the same with prescribed
quality standards and separates defective items from non-
defective ones.
 Inspection, however, does not involve any mechanism to take
corrective action.
MEANING OF QUALITY CONTROL
 Quality Control is a systematic control of various factors that affect the
quality of the product.
 The various factors include material, tools, machines, type of labor,
working conditions, measuring instruments, etc.
 Quality Control can be defined as the entire collection of activities which
ensures that the operation will produce the optimum Quality products at
minimum cost.
 As per A.Y. Feignbaum, Total Quality Control is: “An effective system for
integrating the quality development, Quality maintenance and Quality
improvement efforts of the various groups in an organization, so as to
enable production and services at the most economical levels which allow
full customer satisfaction”
FACTORS AFFECTING QUALITY
 In addition to men, materials, machines and manufacturing
conditions which affect the product quality. Following are
other factors that affect the quality:
 Market Research (to know the requirements of customers).
 Money (Buying power of customers).
 Management (Management policies for quality level).
 Production methods and product design.
 Modern quality control begins with the evaluation of the
customer’s requirements, which plays very significant roles at
every stage of goods manufacturing.
OBJECTIVES OF QUALITY CONTROL
 To decide about the standard of the quality of a product that
is easily acceptable to the customer and at the same time this
standard should be economical to maintain.
 To take different measures to improve the standard of quality
of product.
 To take various steps to reduce any kind of deviations in the
quality of the product during manufacturing.
FUNCTIONS OF QUALITY CONTROL DEPARTMENT
 Only the products of uniform and standard quality are
allowed to be sold.
 To suggest method and ways to prevent the manufacturing
difficulties.
 To reject the defective goods so that the products of poor
quality may not reach to the customers.
 To find out the points where the control is breaking down
and to investigate the causes of it.
 To correct the rejected goods, if it is possible. This
procedure is known as rehabilitation of defective goods.
 Evolution of Quality Control
 Operator quality control period, up to 1900
 The quality of the product could essentially be controlled by a person who was also the operator , and
the volume of production was limited. The worker felt a sense of accomplishment, which lifted morale
and motivated the worker to new heights of excellence.
 Foreman quality control period, up to 1920
 With the Industrial Revolution came the concept of mass production, which was based on the principle
of specialization of labour.
 Inspection quality control period, up to 1940
 Inspectors were designated to check the quality of a product after certain operations. Standards were
set, and inspectors compared the quality of the item produced against those standards.
 Statistical quality control phase, up to 1960
 Production requirements escalated during World War II. Since 100% inspection was often not feasible,
the principles of sampling plans gained acceptance.
 Total quality control organization wide phase, up to now
 Total quality control and Zero defect Phase, Quality circle, Quality tools, etc.
 Quality Characteristics
 Quality Characteristics
 Structural characteristics include such elements as the length of a part, the weight of a
can, the strength of a beam, the viscosity of a fluid, and so on;
 Sensory characteristics include the taste of good food, the smell of a sweet fragrance, and
the beauty of a model, mong others;
 Time - oriented characteristics include such measures as time to process a purchase order,
warranty, reliability, and maintainability associated with a product;
 Ethical characteristics include honesty, courtesy, friendliness, and so on.
 Nonconformity is a quality characteristic hat does not meet its stipulated specifications.
 Quality characteristics fall into two broad classes: variables and attributes.
 Characteristics that are measurable and are expressed on a numerical scale are called
variables.
 A quality characteristic is said to be an attribute if it is classified as either conforming or
nonconforming to a stipulated specification.
 Is the diameter of a bearing a variable or an attribute?
Aspects of Quality
Kano customer satisfaction model
Customer needs or expectations can be
divided into three prioritized categories:
1. basic needs (dissatisfies);
2. performance needs (satisfiers);
3. excitement needs (delighters).
 Standard or Specification
 A standard, or a specification, refers to a precise statement that formalizes the
requirements of the customer; it may relate to a product, a process, or a service.
 For example, the specifications for an axle might be 20 ± 0.1 mm for the inside diameter, 40
± 0.2 mm for the outside diameter, and 100±0.5 mm for the length. This means that for an
axle to be acceptable to the customer, each of these dimensions must be within the values
specified.
 Definitions given by the National Bureau of Standards(NBS,2005) are as follows:
 Specification: a set of conditions and requirements, of a specific and limited application, that
provide a detailed description of the procedure, process, material, product, or service for use
primarily in procurement and manufacturing. Standards may be referenced or included in a
specification.
 Standard: a prescribed set of conditions and requirements, of general or broad application,
established by authority or agreement, to be satisfied by a material, product, process, procedure,
convention, test method; and/or the physical, functional, performance, or conformance
characteristic thereof.
 Quality Control (QC) Methodology
Steps of Quality Control:
 Detection of the problem
 Diagnosis based on the analysis of the causes of the
problem
 Prescription of the corrective actions
 Observations
and evaluations to see how well the
treatment works

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 Seven QC Tools
Seven QC methods described in this presentation include:
1. Cause-and-effect diagram (also called Ishikawa or fishbone
diagrams): Identifies many possible causes for an effect or
problem and sorts ideas into useful categories.
2. Check sheet: A structured, prepared form for collecting and
analyzing data; a generic tool that can be adapted for a wide
variety of purposes.
3. Control chart: Graph used to study how a process changes over
time. Comparing current data to historical control limits leads
to conclusions about whether the process variation is
consistent (in control) or is unpredictable (out of control,
affected by special causes of variation). 30
Seven QC Tools
4. Histogram: The most commonly used graph for
showing frequency distributions, or how often each
different value in a set of data occurs.
5. Pareto chart: A bar graph that shows which factors are
more significant.
6. Scatter diagram: Graphs pairs of numerical data, one
variable on each axis, to look for a relationship.
7. Stratification: A technique that separates data
gathered from a variety of sources so that patterns
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can be seen.
What is a “Cause and Effect Diagram”?
 A cause-effect diagram is a visual tool used to logically organize possible causes for
a specific problem or effect by graphically displaying them in increasing detail,
suggesting causal relationships among theories. A popular type is also referred to as
a fishbone or Ishikawa diagram. Cause-Effect can also be diagrammed using a tree
diagram.
 When diagnosing the cause of a problem, a cause-effect diagram helps to organize
various theories about root causes and presents them graphically.
 The C-E Diagram is a fundamental tool utilized in the early stages of an
improvement team. The ideas generated during a brainstorming or affinity process
are used to populate the diagram. Since the list of issues on a C-E may be very
large, the team should use a prioritization or multi-vote technique to narrow the list
of potential cause that they desire to investigate farther.
 At the head of the diagram is the “Effect” that the team is investigating. The team
brainstormed potential causes for this effect. The skeleton becomes the various
potential causes and the headers are the column heads from the affinity diagram.
Example of a Cause and Effect diagram
Cause-and-effect diagram

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Check Sheet
 A check sheet is a structured, prepared form for collecting and analyzing data.
 Check sheet can be used for:
 When data can be observed and collected repeatedly by the same person or at the same location
 When collecting data on the frequency or patterns of events, problems, defects, defect location,
defect causes, or similar issues
 When collecting data from a production process
 Steps to create a check sheet
 Decide what event or problem will be observed. Develop operational definitions.
 Decide when data will be collected and for how long.
 Design the form. Set it up so that data can be recorded simply by making check marks or X's or
similar symbols and so that data do not have to be recopied for analysis.
 Label all spaces on the form.
 Test the check sheet for a short trial period to be sure it collects the appropriate data and is easy to
use.
 Each time the targeted event or problem occurs, record data on the check sheet.
Check sheet example
The figure below shows a check sheet used to collect data on telephone
interruptions. The tick marks were added as data was collected over several
weeks.
Check Sheet

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Control Charts
 Control Chart is a graph used to study how a process changes over
time. Comparing current data to historical control limits leads to
conclusions about whether the process variation is consistent (in
control) or is unpredictable (out of control, affected by special causes
of variation).
 WHEN TO USE A CONTROL CHART
 When controlling ongoing processes by finding and correcting problems as they
occur
 When predicting the expected range of outcomes from a process
 When determining whether a process is stable (in statistical control)
 When analyzing patterns of process variation from special causes (non-routine
events) or common causes (built into the process)
 When determining whether your quality improvement project should aim to
prevent specific problems or to make fundamental changes to the process
Control Chart

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Histogram
 A histogram is a frequency distribution that shows how often each
different value in a set of data occurs. A histogram is the most
commonly used graph to show frequency distributions.
 Use a histogram when:
 The data are numerical
 You want to see the shape of the data’s distribution, especially when
determining whether the output of a process is distributed approximately
normally
 Analyzing whether a process can meet the customer’s requirements
 Analyzing what the output from a supplier’s process looks like
 Seeing whether a process change has occurred from one time period to another
 Determining whether the outputs of two or more processes are different
 You wish to communicate the distribution of data quickly and easily to others
Histograms

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Histogram Number of Bars
• Number of bars is equal to around square root of the number of data points. For example: 25 data points
= 5 bars, 100 data points = 10 bars.
• Juran's Quality Control Handbook provides the following guidelines for the number of bars and states that
they are not "rigid" and should be adjusted when necessary.
 Pareto Analysis
 Pareto analysis seeks to identify the most frequently occurring causes
of product rejections or quality issues.
 Often, 20 percent of the total number of problems and complaints
occur 80 percent of the time. This is called the 20:80 rule. Some
things occur far more frequently than others.

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Pareto Chart Example
Scatter Diagrams
Scatter diagrams are useful visual aids to find whether there is
a relationship between X and Y.

48
 Life Insurance

Life Insurance Coverage ($ thousands)

Life Insurance
Coverage ($
thousands)
thousands)
160

Income ($
thousands)

Coverage ($

Disposable
Income ($

thousands)
Disposable

140

Insurance Cover
120

100

45 60 65 80 80
40 58 60 90
60
65 100 45 50
50 50 40 50 40

70 120 55 70 20
75 140 55 60
70 100 60 80 0
30 35 40 45 50 55 60 65 70 75 80

40 50 75 120 Disposable Income

50 70 45 50
45 60 65 70
Stratification Diagram

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Process Variation
The causes of process variation can be classified in two categories
 Chance causes
 Assignable causes
Chance Causes
o Chance causes result from inherent (intrinsic and innate) properties of a
stable system.
o These causes cannot be removed, which is why they are called inherent
systems causes.
o A process that experiences only chance causes, no matter what its level
of variability, is called a stable process.
o The variability due to chance causes is called random variation.
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 Process Variation
Assignable Causes:
o The second kind of variability has traceable and
removable causes, which are called assignable or special
causes.
o Unlike chance causes, these causes are not background
noise.
o They produce a distinct trademark, which can be
identified and traced to its origins. It can be removed or
reduced.
o It is also called identifiable systems causes.
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 Stable Process
o For quality to be consistent, it must come from a process that is
stable, i.e., one with fixed parameters. This means that the process
average and its standard deviation are not shifting.
o In the case of measurement by attributes, a stable system will give a
consistent proportion of defective items.
o A process that is operating without any assignable causes of
variation is stable by definition, although its variability can be large.
o Instability reflects the presence of assignable causes of variation,
which create quality problems (e.g., something wears or breaks).
o Process capability studies are used to establish the limits within
which a process can operate.
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Stable and Unstable Process
Normal Distribution
 Capable Process

A stable process that meets customer requirements.

Histogram
Control Chart

UCL

CL

LCL
2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32
Run Order Lower Spec Upper Spec
Target

Capability assessments for unstable processes, may not be indicative of

how the process is actually performing.
 Process Capability
Whether a process is capable of meeting specification refers to the variability
of the product in relation to the specification limits.

Specification
Limits set at:
Frequency

High
Capability 6
Mean
Frequency

Medium
Capability 3
Frequency

Low
Capability 2
 Process Capability Indices
Process Capability Index Cp

Cp = specification range
6 × std. deviation

< 1 = low process capability

1.0 to 1.60 = medium process capability

>1 = high process capability

Primary Responsibility of Quality
 Most quality control experts agree that common causes account
for at least 90% of the quality problems in an organization.
Edwards Deming strongly advocated this belief.
 He concluded that management alone is responsible for common-
cause problems and, hence, only management can define and
implement remedial actions for these problems.
 The operator has no control on nonconforming product or service
in a majority of the instances. Therefore, if a company is
interested in eliminating the root causes of such problems,
management must initiate the problem-solving actions.
 The Taguchi philosophy states that any deviation from the target value
is unacceptable with the loss being proportional to the deviation.
Hence, organisations should strive to reduce the variability.
QUALITY AND PRODUCTIVITY
 A misconception that has existed among businesses is the notion that quality
decreases productivity. On the contrary, the relationship between the two is positive:
Quality improves productivity.
 Making a product right the first time lowers total costs and improves productivity.
More time is available to produce defect-free output because items do not have to be
reworked and extra items to replace scrap do not have to be produced. In fact, doing
it right the first time increases the available capacity of the entire production line.
 As waste is reduced, valuable resources—people, equipment, material, time, and
effort—can be utilized for added production of defect-free goods or services.
 The competitive position of the company is enhanced in the long run, with a
concomitant improvement in profits.
The Quality Define Process
Improvement Model
Select Measures

Collect &
Interpret Data

Is
No
Process Investigate & Fix
Stable Special Causes
?
Yes

No
Is
Improve Process Process
Capability Capable
?
Yes

Use SPC to
Maintain Current
Process
ADVANTAGES OF QUALITY CONTROL
 Quality of product is improved which in turn increases
sales.
 Scraprejection and rework are minimized thus
reducing wastage. So the cost of manufacturing
reduces.
 Good quality product improves reputation.
 Inspection cost reduces to a great extent.
 Uniformity in quality can be achieved.
 Improvement in manufacturer and consumer relations.
QUALITY ASSURANCE
 Quality is not just the responsibility of one person in the organization —this is the message.
 Everyone involved directly or indirectly in the production of an item or the performance of
a service is responsible.
 Unfortunately, something that is viewed as everyone’s responsibility can fall apart in the
implementation phase and become no one’s responsibility.
 This behaviour can create an ineffective system where the quality assurances exist only on
paper. Thus, what is needed is a system that ensures that all procedures that have been
designed and planned are followed. This is precisely the role and purpose of the quality
assurance function.
 The objective of the quality assurance function is to have in place a formal system that
continually surveys the effectiveness of the quality philosophy of the company.
 The quality assurance team audits the various departments and assists them in meeting
their responsibilities for producing a quality product.
QUALITY CIRCLES AND QUALITY IMPROVEMENT TEAMS
 A quality circle is typically an informal group of people that consists of operators, supervisors,
managers, and so on, who get together to improve ways to make a product or deliver a service.
 The concept behind quality circles is that in most cases the persons who are closest to an
operation are in a better position to contribute ideas that will lead to an improvement in it.
 A quality circle can be an effective productivity improvement tool because it generates new
ideas and implements them. Key to its success is its participative style of management.
 A quality improvement team is another means of identifying feasible solutions to quality
control problems. Such teams are typically cross-functional in nature and involve people from
various disciplines.
 It is common to have a quality improvement team with personnel from design and development,
engineering, manufacturing, marketing, and servicing.
 A key advantage of such a team is that it promotes cross-disciplinary flow of information in real
time as it solves the problem.
 When design changes are made, the feasibility of equipment and tools in meeting the new
requirements must be analysed.
Team Effectiveness
 Team objectives should be clearly defined at the beginning of any quality
improvement team project.
 The team leader should prepare and distribute an agenda prior to each meeting.
 Assignments to individual members or subgroups must be clearly identified.
 The team leader should outline the approach, methods, and techniques to be used
in addressing the problem in the beginning.
 The team leader should create a climate for creativity and remove barriers to idea
generation and must encourage differing points of view and ideas.
 All team members should be encouraged to contribute their ideas or to build on
others.
 Regular feedback on the results and actions taken at meetings should be reported.
 Progress should be reviewed systematically, the objective being to come up with a
set of action plans.
STATISTICAL QUALITY CONTROL (SQC):
 Statistics : Statistics means data, normally, a good amount of data to obtain reliable results. The
science of statistics handles this data in order to draw certain conclusions.
 SQC: This is a quality control system employing the statistical techniques to control quality by
performing inspection, testing and analysis to conclude whether the quality of the product is as per
the laid quality standards.
 Using statistical techniques, SQC collects and analyses data in assessing and controlling product
quality.
 The technique of SQC was though developed in 1924 by Dr. Walter A. Shewartan, an American
scientist.
 “Statistical quality control can be simply defined as an economic & effective system of maintaining
& improving the quality of outputs throughout the whole operating process of specification,
production & inspection based on continuous testing with random samples.”-YA LUN CHOU
 “Statistical quality control should be viewed as a kit of tools which may influence decisions to the
functions of specification, production or inspection.-EUGENE L. GRANT
SQC
 The fundamental basis of SQC is the theory of probability.
 According to the theories of probability, the dimensions of the components made on the
same machine and in one batch (if measured accurately) vary from component to
component.
 The variations may be due to inherent machine characteristics or the environmental
conditions.
 SQC is based on the assumptions that the quality of a sample represents the entire batch
or population.
 Based on the above assumption, SQC evaluates a sample to predict and control the
quality of a batch of production.
 SQC uses the following three scientific techniques to control quality:
 Sampling inspection
 Analysis of the data, and
 Control charting
ADVANTAGES OF SQC
 SQC is one of the tools for scientific management, and has following main advantages over 100 percent
inspection:
 Reduction in cost: Since only a fractional output is inspected, hence cost of inspection is greatly reduced.
 Greater efficiency: It requires lesser time and boredom as compared to the 100 percent inspection and
hence the efficiency increases.
 Easy to apply: Once the SQC plan is established, it is easy to apply even by man who does not have extensive
specialized training.
 Accurate prediction: Specifications can easily be predicted for the future, which is not possible even with
100 percent inspection.
 Can be used where inspection needs destruction of items: In cases where destruction of product is necessary
for inspecting it, 100 percent inspection is not possible.
 Early detection of faults: The moment a sample point falls outside the control limits, it is taken as a danger
signal and necessary corrective measures are taken. Whereas in 100 percent inspection, unwanted variations
in quality may be detected after large number of defective items have already been produced.
 Thus by using the control charts, we can know from graphic picture that how the production is proceeding
and where corrective action is required and where it is not required.
Classification of SQC techniques
PROCESS CONTROL
 Process Control consists of the systems and tools used to ensure
that processes are well defined, performed correctly, and
maintained so that the completed product conforms to
established requirements.
 The five elements of a process are:
 People – individuals who manage, plan and operate a process
 Methods/Instructions – documented techniques used to define and
perform a process
 Equipment – tools, fixtures, facilities required to make products
 Material – materials used to manufacture and test products
 Environment – environmental conditions
PROCESS CONTROL SYSTEMS FORMS
 Process control systems can be characterized as one of the
following forms:
 Discrete– Discrete manufacturing involves the production of varieties of
products in very small quantity.
 Batch–Batch manufacturing involves the production of a few variety of
products in batches.
 Continuous– Continuous manufacturing involves production of very large
quantity of an item.
 Different types of production system require different type of quality
control strategies.
STATISTICAL PROCESS CONTROL (SPC)
 SPC is an effective method of monitoring a process through the use of
control charts. Much of its power lies in the ability to monitor both
process center and its variation about that center.
 By collecting data from samples at various points within the process,
variations in the process that may affect the quality of the end product
or service can be detected and corrected, thus reducing waste as well
as the likelihood that problems will be passed on to the customer.
 It has an emphasis on early detection and prevention of problems.
CONTROL CHARTS
 Variations in a manufacturing process are unavoidable.
 A control chart is a graphical representation of the status of the variation of a process.
 It is based on statistical sampling theory, according to which an adequate sized random
sample is drawn from each lot to predict the status of a process.
 Control charts detect variations in the processing and warn if there is any departure from
the specified tolerance limits.
 These control charts immediately tell the undesired variations and help in detecting the
cause and its removal.
 In other words, a control chart is:
 A device which specifies the state of statistical control
 A device for attaining statistical control
 A device to judge whether statistical control has been attained or not.